ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT— 510(k) K955707

Substantially Equivalent

Excel Scientific, Inc.

FDA 510(k) clearance K955707 for ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT, Substantially Equivalent on 1996-05-02. Applicant: Excel Scientific, Inc..

Clearance details

Applicant: Excel Scientific, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1995-12-15
Decision date: 1996-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.